Please click on the images below to download a copy of the relevant certificate;
ISO 13485:2016 Certificate
Medical Devices Regulations 2002 (UKCA) Certificate
MDD Regulation EU 2023/607 Confirmation Letter
Directive 93/42 Medical Devices*
Certificate covers: Sterile Instrument procedure packs, supplementary packs, sterile single use surgical instrument sets, single use surgical instruments for minor surgery, gynaecology, podiatry, opthalmology, ENT and wound care. Please download for more details. *Note certificate shows expiry date of September 2023 however see notes below.
MHRA Guidance Document: The EU has extended the validity of certain Directive 93/42/EEC on medical devices (EU MDD) and Directive 90/385/EEC on active implantable medical devices (EU AIMDD) certificates. Click here for further details.
Please click on the links below to download a copy of the relevant document;
Environmental & Sustatinability Statement
Social Accountability Statement
